Item | Notes |
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Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business) | Currently we have 19 named members, so 2/3 = 12 (excluding chair and government members). |
Open Meeting | 12:10 PM ET, no quorum reached |
Reminder of open action items / outcome of action items | |
Collaborative Community Panel Presentation December 17, 2024 3:50 - 4:20 P | Review proposed answers to the questions |
Content for Collaborative Community website | Received content request from FDA for Collaborative Community website: https://www.fda.gov/about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-health-care-challenges-together Ideas to highlight: Presentations SHIELD members at LOINC 2023 and API 2024; FDA sponsored presentations at LOINC 2024, SNOMED CT 2024 and ASTP 2024
2 presentation proposals submitted for 2025 Provided feedback on 2 federal regulation/initiatives in 2024: USCDI V5 and Proposed HTI-2 Rule List of the speakers on the Special Topics calls in 2024: Synensis Synensys and MIT - Report on Systems-theoretic Process Analysis of data Qulaity in the Lab Data Exchange space Pam Banning (Solventum)- Naming Options for Lab Tests within the LOINC terminology Karim Nashar (NHS)- State of Interoperability in the UK Judith Gillis (Amsterdam University Medical Center) - Comparability of lab results - Experiences in the Netherlands Nancy Cornish (CDC) - Specimen Cross-Mapping-Table Dr. James Crawford (Northwell) - Real World Data on COVID-19 Scott Campbell (University of Nebraska) - SNOMED CT Encoded Cancer Synoptic Reports Giorgio Cangioli - FHIR Lab Report Impelementaiton Guide from HL7 Europe Charley Harper Charlie Harpe (Clinical Architecture) - LOINC Mapping Experiences
4 of active SHIELD Working Groups plus the Steering Committee Total of 104 calls held in 2024 which include: 14 ALL SHIELD Community calls 9 Special Topic calls 62 Working group calls (32 LIDR+7 standards+17 comms+6 IVD) 19 Steering Committee calls
Several members of SHIELD are supporting HITACH HITECH and Sequoia Laboratory Data Interoperability Implementation Guide 5 articles referencing SHIELD work, which are linked to from our website https://aphlinformatics.atlassian.net/wiki/spaces/SC/overview?homepageId=986579060
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Conferences | ASCLS got submitted - waiting for response ADLM got submitted - waiting for response |
Other presentations to folks at FDA? | |
Review Working Groups progress | THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid |
Administrative things | Review SC Composition, terms and requirements for re-voting: Representative first 3 year terms expire 12/20/2025 Chair and Vice Chair 2 year terms expire 3/14/2025 90 days would be 12/14/2024 for call for nominations for Chair and Vice-Chair, so folks, start thinking about who might want to take the reins  email Andrea and Riki with any nominations what do we do if we don't get nominations? maybe switch positions of existing SC members ask on ALL SHIELD call for self-nominations to the SC ask the professional organization members to distribute further than SHIELD list for interest in participaiton in general
Steering Committee attendance review and proposed members to be replaced due to non-attendance / participation: Doodle Poll outcome: Best time for most folks is still TBD
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Roadmap section updates in response to ONC comments on the SHIELD roadmap | The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub. ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context.
Updated language draft:Roadmap update: ONC Feedback maybe add one more sentence or add a reference to the key consideration number for the IVD Datahub (Consideration 4) into these sentences. (change approved in principle.) Discussion: The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier.
Update from Standards and Vocab WG about re-write of this section - from their March 18th call (notes here, recording here) Concepts around Healthcare IT (HIT) standards needs to be conveyed earlier in training for healthcare providers as use and application of standards in vended applications is the major gap. Decision making to use Health IT standards are less likely left up to IT analysts as they mainly follow the requirements and then they generally use vendor supplied implementation guidance. However, a vendor may not support functionality for standards or only partially support. Regulatory requirements (such as CLIA) may pose a hurdle to implementation of data standards. Implementation guidance is often not well read. Training resources may not be well publicized or readily available. Perhaps conformance testing tools need to be made more widely available? What might be helpful is to look at standards implementation from a data lifecycle standpoint across all users (end to end across ecosystem), rather than just training on a single standard for a single use case. Last paragraph on page 4 of the road map final version could be augmented with these points.
Discussion: There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap. ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).
Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working. For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption. |
Antimicrobial result reporting | Placeholder to get back to later Related work at HL7 Europe: | View file |
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| name | EU coded value sets.xlsx |
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Next calls | All SHIELD Calls December 17th January 28th
General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to) Special Topic: Steering Committee: |
Adjourned | 12: PM ET |